human subjects
What It Means
Human subjects are real people whose personal information, behavior, or biological samples are collected, studied, or analyzed as part of research activities. This includes anyone whose data is gathered through surveys, interviews, observations, medical tests, or even through analyzing their existing records or digital footprints. The key factor is that researchers are studying actual people rather than anonymous datasets or theoretical models.
Why Chief AI Officers Care
AI projects involving human subjects trigger strict federal research regulations that require institutional review board approval, informed consent processes, and ongoing compliance monitoring. Violating these rules can result in severe penalties including loss of federal funding, legal liability, and reputational damage. Many AI training datasets and user studies inadvertently involve human subjects, making this a hidden compliance landmine for AI initiatives.
Real-World Example
A company training an AI chatbot by analyzing customer service transcripts would be conducting human subjects research, since they're studying identifiable information about real customers' communications. Even if names are removed, the combination of conversation patterns, timestamps, and account details could still identify individuals, triggering the need for IRB approval and potentially customer consent.
Common Confusion
Many assume that using anonymized or publicly available data automatically exempts them from human subjects regulations, but this isn't true if individuals can still be identified through data combination or if the research involves private information. Additionally, employee data and user analytics often qualify as human subjects research even when companies view it as routine business operations.
Industry-Specific Applications
See how this term applies to healthcare, finance, manufacturing, government, tech, and insurance.
Healthcare: In healthcare research, human subjects include patients participating in clinical trials, individuals in medical studies...
Finance: In finance, human subjects include customers, employees, or investors whose personal data, financial behaviors, or trans...
Premium content locked
Includes:
- 6 industry-specific applications
- Relevant regulations by sector
- Real compliance scenarios
- Implementation guidance
Technical Definitions
NISTNational Institute of Standards and Technology
"a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens."Source: 45_CFR_46_2018_Requirements_(2018_Common_Rule)
Related Terms
Discuss This Term with Your AI Assistant
Ask how "human subjects" applies to your specific use case and regulatory context.
Start Free Trial